Originally published as JCO Early Release 10.1200/JCO.2004.00.0497 on October 17 2005

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Randomized Comparison of Weekly Cisplatin or Protracted Venous Infusion of Fluorouracil in Combination With Pelvic Radiation in Advanced Cervix Cancer: A Gynecologic Oncology Group Study

From the Department of Radiation Oncology, Delaware County Memorial Hospital, Drexel Hill, PA; Radiation Oncologist, St Joseph's Hospital/Cancer Institute, Tampa, FL; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; University of Oklahoma, Oklahoma City, OK; Department of Gynecologic Oncology, University of Texas, Galveston Medical Branch, Galveston, TX; Department of Obstetrics/Gynecology, Indiana University School of Medicine, Indianapolis, IN; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of California-Irvine Medical Center, Orange, CA; and Norton Healthcare Inc, Clinical Pathology Associates, Louisville, KY

Address reprint requests to Rachelle Lanciano, MD, Radiation Oncology, Delaware County Memorial Hospital, 501 N Lansdowne Ave, Drexel Hill, PA 19026; e-mail: rlancmd{at}aol.com

PURPOSE: Concurrent chemoradiotherapy is the standard of care for locally advanced cervix cancer; the optimal chemotherapy regimen is not yet defined. This trial was designed to compare the outcome of protracted venous infusion (PVI) fluorouracil (FU) with standard weekly cisplatin and concurrent radiation therapy (RT).

PATIENTS AND METHODS: Patients with stage IIB, IIIB, and IVA cervical cancer with clinically negative aortic nodes were eligible. Pelvic RT dose was 45 Gy with a parametrial boost to involved sides of 5.4 to 9 Gy, and high- or low-dose rate intracavitary brachytherapy. Standard therapy was weekly cisplatin 40 mg/m², and experimental therapy was PVI FU 225 mg/m²/d for 5 d/wk for six cycles during RT.

RESULTS: The study was closed prematurely when a planned interim futility analysis indicated that PVI FU/RT had a higher treatment failure rate (35% higher) and would, most likely, not result in an improvement in progression-free survival compared with weekly cisplatin/RT. The PVI FU/RT arm continues to show a higher risk of treatment failure (relative risk [RR] unadjusted, 1.29) and a higher mortality rate (RR unadjusted, 1.37). There was no difference in pelvic treatment failure between regimens, but there was an increase in the failure rate at distant sites in the PVI FU arm.

CONCLUSION: In this study, PVI FU does not show improved outcome over weekly cisplatin. Future research should explore combinations of FU with cisplatin, new radiosensitizers, and active drugs combined with RT to reduce the high rate of pelvic and distant treatment failure still seen in advanced cervix cancer.

Supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (Grant No. CA 27469) and the Gynecologic Oncology Group Statistical Office (Grant No. CA 37517).

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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